MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ERGOSTAR CM 45; CONNECTOR, AIRWAY (EXTENSION)

Model Number	MP01845
Medical Device Problem Codes	Disconnection (1171); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported that the ergostar (catheter mount) had a loose connection and slipped off during use.No injury reported.
Additional Manufacturer Narrative
The affected ergostar cm45 was requested several times for the investigation but was not received.Therefore, an analysis of the reported issue was not possible and a root cause could not be determined.It is obvious to the user when the ergostar loosens and slips off.In addition a corresponding alarm is posted by the connected main device to inform the user.In the last 12 months no similar complaint has been reported.
Event or Problem Description
It was reported that the ergostar (catheter mount) had a loose connection and slipped off during use.No injury reported.

• Brand Name: ERGOSTAR CM 45
• Common Device Name: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 23603259
• Report Number: 9611500-2025-00641
• Device Sequence Number: 13122704
• Product Code: BZA
• UDI-Device Identifier: 04048675420729
• UDI-Public: (01)04048675420729
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MP01845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown